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Contact Lens in Pediatrics (CLIP) in an Asian Population Study (CLIP)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This is a bilateral, open-label dispensing evaluation of two daily lens types. Eligible subjects will wear the study lenses for 3-months daily wear. 1-Day Acuvue will be worn by spherical subjects and 1-Day Acuvue for Astigmatism will be worn by astigmats.
There is a total of 4 study visits (baseline, contact fitting and dispensing, 1 week, 1 month and 3 month follow-up). Tests conducted include manifest refraction and over-refraction, keratometry, visual acuity, ACA ratio, lens fit assessment, slit lamp biomicroscopy and parent/patient questionaires.
Each child was provided with a supply of lenses to last until the next scheduled follow-up visit, unit-dose rewetting drops for rinsing their lenses if necessary, and a daily log to complete each day until the next follow-up visit.
Informed consent was obtained from all subjects after the nature of the study had been fully explained. The study gained approval from the Ethics Committee of the Singapore Eye Research Institute.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Singapore, Singapore
- Singapore National Eye Centre
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Be between 8-11 years of age.
- Signed Written Informed Consent and/or have the consent of a parent or legal guardian and Investigator to record this on Case Report Form (CRF) in appropriate space.
- Be a neophyte.
- Require a visual correction in both eyes.
- Require a soft contact lens spherical correction between +5.00 and -9.00 DS.
- Have an astigmatic correction between 0.00 amd 2.00 DC.
- Be able to wear the lens powers available for this study.
- Be correctable to a visual acuity of 20/25 or better in each eye.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
(i)No amblyopia. (ii) No evidence of lid abnormality or infection. (eg. entropion, ectropion, chalazia, recurrent styes). (iii) No clinically significant slit lamp (eg. any infiltrates or other slit lamp findings Grade 3 or above: corneal edema, corneal staining, tarsal abnormalities, conjunctival injection, vascularisation, or abnormal opacities).(iv) No other active ocular disease. (eg. glaucoma, history of recurrent corneal erosions, cornea infiltrates, conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.)
Exclusion Criteria:
- Requires concurrent ocular medication.
- Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
- No clinically significant (Grade 3 or 4) slit lamp findings including corneal edema, corneal vascularization, corneal staining, tarsal abnormalities, bulbar injection, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Diabetic.
- Infectious disease (eg.hepatitis, tuberculosis)or an immunosuppressive disease (eg.HIV).
- PMMA or RGP lens wear in the previous 8 weeks.
- Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.
- Abnormal lacrimal secretions.
- Pre-existing ocular irritation that would preclude contact lens fitting.
- Keratoconus or other corneal irregularity.
- Pregnancy, lactating or planning a pregnancy at the time of enrollment only.
- Participation in any concurrent clinical trial.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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i. demographics ii. refraction (D) visual acuity iii. AC/A Ratio (phorias in prism dioptres) iv. Keratometry v. Slit lamp examination vi. Corneal staining viii. Contact lens fit assessment
Tijdsspanne: December 2006 to July 2007
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December 2006 to July 2007
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Questionaire filling by subject/parent
Tijdsspanne: Dec 2006 to July 2007
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Dec 2006 to July 2007
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Li Lim, FRCS(Ed), Singapore Eye Research Institute
Publicaties en nuttige links
Algemene publicaties
- Sankaridurg PR, Sweeney DF, Holden BA, Naduvilath T, Velala I, Gora R, Krishnamachary M, Rao GN. Comparison of adverse events with daily disposable hydrogels and spectacle wear: results from a 12-month prospective clinical trial. Ophthalmology. 2003 Dec;110(12):2327-34. doi: 10.1016/S0161-6420(03)00795-4.
- Suchecki JK, Ehlers WH, Donshik PC. A comparison of contact lens-related complications in various daily wear modalities. CLAO J. 2000 Oct;26(4):204-13.
- Solomon OD, Freeman MI, Boshnick EL, Cannon WM, Dubow BW, Kame RT, Lanier JC Jr, Lopanik RW, Quinn TG, Rigel LE, Sherrill DD, Stiegmeier MJ, Teiche RS, Zigler LG, Mertz GW, Nason RJ. A 3-year prospective study of the clinical performance of daily disposable contact lenses compared with frequent replacement and conventional daily wear contact lenses. CLAO J. 1996 Oct;22(4):250-7.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R501/50/2006
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